1. Field of the Invention
The present invention relates to means and methods for aseptic, particle-free production of articles, and in particular, to means and methods for producing both externally and internally sterilized, particle-free articles which are manufactured under high temperature and/or high pressure.
2. Problems in the Art
There are many products which are desired to be, or out of necessity need to be, sterilized and particle-free. For example, the pharmaceutical and health care industries, of necessity, require aseptic instruments, containers, caps, plugs, and the like. Similarly, semiconductor electronic component production requires a particle-free and sterilized environment to ensure reliable and quality articles. Such need is well known within these arts. It is to be understood that the term "particle-free", as used herein, means "particle-reduced" or "particle-minimized", as it is virtually impossible to eliminate all foreign particles from a manufactured container.
In the case of containers for pharmaceuticals or other health care products, sterile conditions must exist not only for the interior of the container and caps, but also for the exterior of all portions of the container and caps prior to filling. Thus, it is critical that aseptic conditions exist in the manufacturing of the containers and caps to allow them to be sterile and particle-free when they are filled and sealed.
Conventionally, pharmaceutical or health care containers and caps were sterilized by imparting sterilizing gas, such as steam or EtO, onto the articles, or by applying gamma radiation to the articles. These conventional methods may be referred to as "secondary" sterilization methods, since the sterilization step is preformed subsequent to formation of the articles. While such procedures have proved adequately effective for sterilization in appropriate circumstances, they require additional and significant equipment, time, and cost over and above that needed for the manufacturing of the articles. Also, significant health risks and hazards accompany the use of EtO.
It is also known that in many applications, such as making pharmaceuticals or in laboratories, foreign particles may be minimized by using "clean-room" procedures. "Clean-room" procedures include sterilizing the surfaces involved in the process or processes taking place therein, filtering the air in the room, and having workers use sterilized gloves, lab coats, masks, hats, etc. Such procedures do not ensure sterility, but rather tend only to reduce contamination or enhance the probability of sterility. Additionally, such procedures reduce larger particle contamination, but may not be effective for the very smallest contaminating particles such as micro-organisms.
It is therefore a primary objective of the present invention to provide a means and method for aseptic, particle-free production of articles, which improves over or solves the problems and deficiencies in the art.
Another object of the invention is to provide a means and method as above described which eliminates conventional sterilization steps, equipment, costs, and handling while producing aseptic, particle-free articles.
A further object of the invention is to provide a means and method as above described which can provide a sterile environment for both production and handling of articles.
A further object of the present invention is to provide a means and method as above described which can produce internally and externally sterile and particle-free articles.
Another object of the present invention is to provide a means and method as above described which can be applied to the production of any type of component manufactured under high temperatures and/or pressures.
A further object of the invention is to provide a means and method as above described which can produce sterile and particle-free articles whether the articles be solid or have hollowed places or interior sections.
A further object of the invention is to provide a means and method as above described which eliminates or greatly reduces the use of chemicals or irradiation.
Another object of the present invention is to provide a means and method as above described which is economical, flexible in use, efficient, safe, and reliable.
A further object of the present invention is to provide a means and method as above described which may be retrofitted to existing production machines and techniques.
These and other objects, features, and advantages of the present invention will become more apparent with reference to accompanying specification and claims.